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A Comparison of Risperidone and Aripiprazole for Treatment of Patirnts With Methamphetamine-Associated Psychosis

This study has been terminated.
(Effects of aripiprazole was not obvious and showed adverse reaction obviously)
Information provided by (Responsible Party):
Wei Hao, Central South University Identifier:
First received: August 19, 2012
Last updated: February 2, 2015
Last verified: February 2015
Methamphetamine-associated psychosis (MAP) has been considered a pharmacological or environmental pathogen model of schizophrenia (SCZ) due in part to similarities in clinical presentation (i.e. paranoia, hallucinations, disorganized speech, and negative symptoms), response to treatment (e.g.neuroleptics),and pathologic mechanisms (e.g. central dopaminergic neurotransmission) of both conditions. Both risperidone and aripiprazole are second generation antipsychotics,but have different pharmacological effects of antipsychotic treatment.This study was designed to examine the acute efficacy, safety, and tolerability of risperidone and aripiprazole for patients with MAP.

Condition Intervention Phase
Methamphetamine Dependence
Drug: Risperidone
Drug: Aripiprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple-Center, Randomized, Double-Blind Study of Comparison of Risperidone and Aripiprazole for Treatment

Resource links provided by NLM:

Further study details as provided by Central South University:

Primary Outcome Measures:
  • The severity of psychosis [ Time Frame: up to 4 weeks. participants will be followed for the duration of hospital stay ]
    Positive and Negative Syndrome Scale

Secondary Outcome Measures:
  • adverse drug reaction [ Time Frame: up to 4 weeks. participants will be followed for the duration of hospital ]
    Barnes Scale , Simpson-Angus Scale , Abnormal Involuntary Movement Scale

  • Clinical general status [ Time Frame: up to 4 weeks. participants will be followed for the duration of hospital stay ]
    Clinical general rating scale

Enrollment: 50
Study Start Date: July 2012
Study Completion Date: August 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aripiprazole
Aripiprazole arm,5mg/pill,20-30mg/day,non-forced titration method.last2-4weeks.
Drug: Aripiprazole
Aripiprazole group,5mg/pill,20mg-30mg/day non-forced titration method,last 2-4weeks
Other Name: Aopai H20041507
Active Comparator: Risperidone
Risperidone arm and placebo tables,1mg/pill,2mg-6mg/day,non-forced titration method.last2-4weeks.
Drug: Risperidone
Risperidone group,1mg/pill,2mg-6mg/day non-forced titration method,last 2-4weeks
Other Name: Risperdal H20070057

Detailed Description:
Methods:A Multiple-Center, Randomized, Double-Blind.

Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients,Diagnostic and Statistical Manual of Mental Disorders 4thed. (DSM-IV) criteria for Methamphetamine-Associated Psychosis.
  2. Must sign a Information consent form.
  3. Required to provide detailed address and phone number

Exclusion Criteria:

  1. Serious organic disease.
  2. Suicide ideation or hurt others.
  3. Taking antipsychotic within two weeks before.
  4. drug allergy to Risperidone or Aripiprazole.
  5. pregnancy and breastfeeding women.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01813643

China, Hunan
The Second Xiangya Hospital of Central University
Changsha, Hunan, China, 410011
Sponsors and Collaborators
Wei Hao
Study Director: Wei Hao, MD., Ph.D. Central South University
  More Information

Responsible Party: Wei Hao, The Second Xiangya Hospital of Cental South University, Central South University Identifier: NCT01813643     History of Changes
Other Study ID Numbers: 100000-068941
Study First Received: August 19, 2012
Last Updated: February 2, 2015

Keywords provided by Central South University:
Methamphetamine-Associated Psychosis

Additional relevant MeSH terms:
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors
Serotonin Antagonists
Serotonin Agents
Dopamine Antagonists processed this record on April 28, 2017